What is the most important information I should know about setmelanotide?
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
What is setmelanotide?
Setmelanotide is used to help with weight loss and control of hunger in people with certain genetic deficiencies who are 6 years and older.
Your doctor will perform tests to make sure setmelanotide is the right treatment for you.
Setmelanotide may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving setmelanotide?
Tell your doctor if you have ever had:
- kidney disease;
- depression, or suicidal behavior or thoughts; or
- darkened skin, including skin discoloration.
Losing weight when you are pregnant may harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.
Setmelanotide may contain an ingredient that can cause serious side effects or death in very young or premature babies. Do not give this medicine to a child without medical advice.
How is setmelanotide given?
Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.
Setmelanotide is injected under the skin once a day when you wake up, at the beginning of the day.
You may use setmelanotide with or without food.
Ask your doctor or pharmacist if you don't understand how to use an injection.
Prepare an injection only when you are ready to give it. Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.
Do not reuse a needle or syringe. Place them in a puncture-proof "sharps" container and dispose of it following state or local laws. Keep out of the reach of children and pets.
Your doctor may tell you to stop using setmelanotide if you have not lost certain amount of weight after a certain time of treatment.
You should have a skin exam before starting and during treatment with setmelanotide.
Follow all storage instructions provided with setmelanotide. Your pharmacist can provide more information about how to store this medicine.
What happens if I miss a dose?
Skip the missed dose and use your next dose at the regular time. Do not use two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving setmelanotide?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
What are the possible side effects of setmelanotide?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Some people have thoughts about suicide while using setmelanotide. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.
Call your doctor at once if you have:
- an erection lasting longer than 4 hours.
Common side effects may include:
- bruising, swelling, warmth, redness, oozing, or bleeding where an injection was given;
- skin darkening;
- erection without any sexual activity in males; or
- nausea, vomiting, diarrhea, or stomach pain.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect setmelanotide?
Other drugs may affect setmelanotide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your doctor or pharmacist can provide more information about setmelanotide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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